Effects of Upgrading From Right Ventricular Pacing to Cardiac Resynchronization Therapy and Comparison With Dual-Chamber Defibrillator

NCT ID: NCT07077928

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

307 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients who consecutively underwent de novo CRT implantation, CRT upgrade, and DDDR ICD implantation at the Cardiology Clinic of Bursa Postgraduate Hospital between January 2019 and December 2023 according to the European Society of Cardiology (ESC) guideline criteria were included in the study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

100 patients receiving de-novo CRT, 38 patients upgrading from RV pacing to CRT, and 169 patients receiving a DDDR-ICD implantation were included the study. Inclusion criteria were left ventricular ejection fraction lower than 35% and either QRS longer than 130ms for CRT groups or QRS≤120ms for the DDDR-ICD group. Primary endpoints were all-cause mortality and hospitalization for heart failure during a follow-up period extending up to 5 years.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Ventricular Arrhythmias and Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pacemaker upgrade

CRT upgrade

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

De novo CRT group:

* Sinus rhythm,
* age higher than 18,
* EF lower than 35%,
* New York Heart Association (NYHA) class II-IV,
* QRS \>130 ms,
* patients with atrial fibrillation (AF) who converted to sinus rhythm and who remained symptomatic despite 3-6 months of guideline-directed medical therapy.

CRT upgrade group:

* Sinus rhythm,
* age higher than 18,
* EF lower than 35%,
* NYHA class II-IV,
* QRS duration \>130 ms with RV pacing,

-\> 20% RV pacing rate,
* patients with AF who converted to sinus rhythm, at least 6 months since pacemaker implantation, and symptomatic despite 3-6 months of guideline directed medical therapy.

DDDR ICD group:

* Sinus rhythm,
* age higher than 18,
* EF lower than 35%,
* QRS ≤120 ms,
* NYHA class II-IV,
* patients with AF converted to sinus rhythm,
* receiving guideline-directed medical therapy.

Exclusion Criteria

* patients with atrial fibrillation
* LV EF higher than 50 %
* NYHA Class 1
* Patients with active infection or cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bursa Postgraduate Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hasan ARI

Professor Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bursa Yüksek İhtisas Hastanesi

Bursa, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Bursa PH CRT Upgrade

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pacing in Heart Failure With Preserved LVEF
NCT03215849 ENROLLING_BY_INVITATION NA